Can my medical device be produced by a non-ISO 13485 certified manufacturer?
To have or not to have? To certify or not? You want to produce a medical device. So, you decide to hire […]
Read moreTag: Risk
Want to apply risk-based thinking? This you should know
ISO 13485:2016 requires companies to use risk-based thinking to manage their business. Risk is inherent in all aspects of a QMS. There […]
Read moreRisk Management according to ISO 14971
In a fast-paced world, the risks companies are exposed to have to be managed in order to continue to grow and develop, […]
Read moreWhat risk-based approach to QMS means?
The new version of the ISO 13485:2016 standard expects companies to apply a “risk-based approach” to all their QMS processes, exactly stating they […]
Read more